Kornimate/medical-research-clean huggingface dataset:
prochlorperazine maleate versus placebo for the prophylaxis of acute mountain sickness

Conditions: Acute Mountain Sickness

Summary: this study is a trial looking at a drug to help prevent acute mountain sickness. the drug is prochlorperazine, a drug commonly used to treat nausea vomiting and headache. participants will either take the drug or a placebo, and hike to and sleep at the summit of mount blue sky located at 4,348 meters (14,265 feet).

this study will be a double-blind randomized controlled trial to investigate the utility of prochlorperazine maleate versus placebo for the chemoprophylaxis of acute mountain sickness on rapid ascent to 4,348 meters, specifically the summit of mount blue sky in the mount blue sky wilderness. participants will be evaluated for ams utilizing the 2018 llq both the evening of and morning after ascent. the primary outcome will be the presence of ams, defined by a 2018 llq score equal to or greater than 3, including the presence of a headache at any measured point during the study. individuals will convene the morning of the study in golden, colorado where they will receive breakfast and either placebo or prochlorperazine. they will then be driven to summit lake where they will break for lunch and receive the second dose of placebo or prochlorperazine. they will then hike to the mount blue sky summit where they will receive their third and final dose of either placebo or intervention, spend the night in the structures at the summit, and be assessed for ams via llq. in the morning, they will be assessed for ams again, receive breakfast, and then be driven back to the original meeting point. they will be monitored by emergency physicians at all points during the study.

Eligibility criteria:
inclusion criteria: * adults \>18 years old. exclusion criteria: * individuals \ 75 years old * pregnant women * individuals who reside at or have slept at elevations \>1,800 meters in the last two weeks * individuals having taken acetazolamide, steroids, ibuprofen, anti-emetics or additional analgesics within the last 24 hours prior to study initiation * individuals requiring supplemental baseline oxygen or with chronic disorders known to be significantly impacted by hypoxia * individuals with known allergies to prochlorperazine or phenothiazines * individuals taking medications with significant medication interactions with prochlorperazine: dofetilide, potassium acid phosphate, potassium chloride, potassium citrate, potassium phosphate, yohimbe. * individuals with a history of dementia * individuals who lack decision making capacity
glargine insulin vs.continuous regular insulin in diabetic surgical patients receiving parenteral nutrition (glucose-in-pn)

Conditions: Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition

Summary: hyperglycemia increases the risk of complications in surgical patients. focus on poor glycemic control as a contributor to adverse outcomes in settings outside the intensive care unit (icu) is often dismissed. total parenteral nutrition (tpn) has been used in providing surgical patients with nutrition to prevent deterioration of nutritional status. however, many diabetic patients receiving tpn develop exaggerated hyperglycemia that requires frequent insulin administration via sliding scale. providing diabetic patient's receiving tpn basal insulin is a known strategy to aid in blood sugar control and prevention of high blood sugar spikes. many strategies for basal insulin provision have been utilized clinically during the administration of tpn; this includes the incorporation of insulin with tpn solution or administration of long acting insulin such as glargine. however, no study has compared any of these strategies aiming for selecting the optimum modality for controlling blood glucose in diabetic surgical patient's receiving tpn. we will conduct a study to compare the efficacy of once daily insulin glargine versus continuous regular insulin incorporated tpn in controlling blood glucose in non-critically ill diabetic surgical patients receiving tpn.


Eligibility criteria:
inclusion criteria: * all adult diabetic patients undergoing abdominal surgery operated by the surgical oncology team at kfsh \& rc and required tpn therapy are possible subjects of the study. exclusion criteria: * patients receiving octreotide or immunosuppressive agents including corticosteroids. * recipient of \< 3 units of regular insulin per day via subcutaneous insulin sliding scale after the third day of tpn recipient. * patients with clinically relevant hepatic disease (\> three times normal ast and alt on admission to the hospital) or impaired renal function (gfr \< 60 ml/min), history of diabetic ketoacidosis. patients who get infected while on tpn as reflected with elevation of white blood cells and elevated temperature \> 37.5 c will be excluded as well.

Keywords: parenteral nutrition hyperglycemia glargine insulin regular insulin
complex post market surveillance electronic registry

Conditions: Intracranial Aneurysm

Summary: to demonstrate performance of trufill dcs and trufill dcs orbit detachable coils in the treatment of aneurysms.

this post market surveillance registry collect baseline characteristics, aneurysmal features, procedural and follow-up information, and complications/adverse events on the performance intracranial aneurysms treated with the trufill dcs orbit detachable platinum coils.

Eligibility criteria:
inclusion criteria: 1. patients with angiographically documented aneurysms, 2. either ruptured or unruptured, 3. aneurysm deemed by the attending neurointerventionalist to be acceptable candidates for endovascular embolization exclusion criteria: 1) patient / treatment outside of the approved labeling, indications for use.

Keywords: intracranial aneurysm
inec study: immuno-modulating enteral nutrition in cancer

Conditions: Malnutrition; Esophageal Cancer; Head and Neck Cancer

Summary: the aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet \[impact (r), novartis\] versus a standard enteral nutrition (control, novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.

malnutrition is frequent in head and neck (h\&n) and esophageal cancers and alters immune status, anti-infectious and anti-tumoral defenses and the response to the treatment (surgery, chemotherapy, radiotherapy). treatment of these 2 types of cancer is often chemoradiotherapy which frequently induces mucositis. mucositis enhances nutritional risk and could impose a modification or an interruption of the treatment. the aim of this study is to investigate if enteral immunonutrition of head and neck or esophageal cancer patients, using an arginine, omega 3 fatty acid, nucleotides-enhanced diet \[impact(r), novartis\] versus a standard enteral nutrition (control, novartis), could improve clinical outcomes (mucositis frequency, treatment tolerance), nutritional and immune status, and life quality parameters.

Eligibility criteria:
inclusion criteria: * h\&n and esophageal cancer patients, not treated by surgery and needing chemoradiotherapy * performance status: objective mucositis score (oms) of 0, 1, 2 or karnofsky \> 50% * acceptance of a gastrostomy, jejunostomy or a nasogastric tube to conduct enteral nutrition * informed consent form signed exclusion criteria: * h\&n cancer treated by exclusive radiotherapy * h\&n and esophageal cancer which can be treated by exclusive surgery * tonsil cancer * existence of metastases * concomitant cancer * repeat of cancer at site * insulin dependant diabetes * thyroid diseases * subjects with major surgery or severe infectious status in the 3 preceding months * biological assessment incompatible with the esophagus chemotherapy treatment (polynuclear cells \ 130 µmol/ml; asat, alat, alp and bilirubin \> twice the norm) * patients taking food or supplements enriched with omega 3 (arginine and nucleotides), during the period of the study and in the preceding month * breast feeding women or in period of fertility without effective means of contraception * patients who refuse to participate or are unable to receive information or are unable to sign written informed consent.

Keywords: enteral nutrition immunonutrients head and neck cancer esophageal cancer chemoradiotherapy h&n or esophageal cancer patients with a chemoradiotherapy treatment.
osteopathy in chronic obstructive pulmonary disease (copd) rehabilitation trial

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this trial is to verify if an osteopathic treatment added to usual pulmonary rehabilitation trial is able to improve the walking ability of copd patients and if there is any influence on lung functionality.

the investigators decided to perform an osteopathic manipulative treatment (omt) in a population of copd patients. omt was defined as the therapeutic application of manually guided forces by an osteopathic practitioner to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. concerning the respiratory system, osteopathy considers a model that describes the interdependent functions among five body components as follows: 1: the inherent motility of the brain and spinal cord; 2: fluctuation of the cerebrospinal fluid; 3: mobility of the intracranial and intraspinal membranes; 4: articular mobility of the cranial bones; 5: the involuntary mobility of the sacrum between the ilia. this model is the so called primary respiratory mechanism.

Eligibility criteria:
inclusion criteria: * patients affected by copd exclusion criteria: * other diseases other than copd

Keywords: copd
diacon dual-hormone closed-loop glucose control

Conditions: Type 1 Diabetes

Summary: the ultimate t1d treatment tool is a closed-loop glucose control system, i.e. a fully automated system for intensive insulin treatment. such system will ease the burden of constant treatment decision-making and at the same time it has the potential to safely intensify insulin therapy such that more patients can reach treatment goals. currently, no off-the-shelf closed-loop system exists but research efforts in this field have been intensified and resulted in great progress in recent years. most closed-loop systems consist of an insulin pump, a cgm, and a control algorithm residing on a mobile computer that continuously (every 5-15 min) computes the optimal insulin dosage from the cgm values. for daytime blood glucose control, however, we believe that the system needs to be further advanced. consequently, we have extended our single-hormone closed-loop system such that it now includes a second pump for glucagon delivery and correspondingly we have further developed our control algorithm to compute both insulin and glucagon dosages. we hypothesize that we have developed a safe and effective dual-hormone closed-loop system for patients with type 1 diabetes and that this system is superior to single-hormone closed-loop therapy. the aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.


Eligibility criteria:
inclusion criteria: * t1d ≥ 2 years * insulin pump therapy with rapid-acting analog insulin ≥ 1 year * hba1c ≤ 8.5% (69 mmol/mol) * ability and willingness to comply with all protocol procedures exclusion criteria: * pregnancy or nursing * plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection) * hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is \< 3.0 mmol/l) * use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation * history of coronary artery disease or congestive heart failure * abnormal ecg suggestive of coronary artery disease and increased risk of malignant arrhythmia * allergy to glucagon or lactose * pheochromocytoma * other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
comparison of hiv testing algorithms

Conditions: HIV Infection

Summary: the primary objective of the study is to assess whether an improved msf hiv diagnostic algorithm which includes a simple and easy to perform confirmation test has significantly better positive predictive value than who recommended rdt testing algorithms that do not include confirmatory testing.

rapid diagnostic tests (rdt's) are essential tools in antiretroviral treatment (art) scale up. an important drawback to rdts is the risk of false positive results. in 2005, msf-holland has therefore changed the testing algorithm to introduce a confirmation test. this proposal outlines an evaluation study of the results of the new confirmatory testing algorithm. it aims to compare the confirmatory algorithm employed by msf-oca to the moh serial algorithm which is based on who recommendations. a secondary objective of the study is to determine if there is a correlation between kala-azar infection and risk of false positive hiv rdt results as clinicians in the projects suspect such a correlation. furthermore, the study will look at the positive predictive value of weak test lines, which have been associated with higher risk of false positive results. finally, the study aims to evaluate the results of a new simplified confirmation test, the dilution testing. clients for the study will be recruited at two counseling and testing sites in abdurafi and humera, aiming to reach a sample size of 200 serial-algorithm positive and 200 negative samples in each site.

Eligibility criteria:
inclusion criteria: * • age \>= 59 months (to help ensure success of venepuncture) * informed consent from the individual or guardian to participate in study exclusion criteria: * • inability to obtain venous blood sample * withdrawal of consent to test or to participate in the study

Keywords: hiv diagnostics
a comparison of prevention of hypothermia in pediatric patient between wrapping with cotton and plastic.

Conditions: Perioperative Hypotension; Prevention; Child

Summary: hypothermia leads to increased morbidity and mortality. heat loss mainly occurs during anesthesia and surgery. therefore prevention of hypothermia in pediatric patients undergoing general anesthesia is very important. however, there is very little information about effectiveness of various insulating materials used in the operating room. objective: to compare the effectiveness of cotton and plastic for prevent intraoperative hypothermia in pediatric patients.

a randomized controlled trial was conducted in 42 pediatric patients (age 1 month-3 years, asa physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery. the patients were randomly allocated into 2 groups. the patient's arms, legs and bodies were wrapped with either plastic (study group) or cotton (control group). all patients received standard general anesthesia with endotracheal tube and control ventilation with a fresh gas flow at 1 l/min. the core temperature (rectal temperature) was recorded every 10 minutes for 60 minutes.

Eligibility criteria:
inclusion criteria: * 42 pediatric patients (age 1 month-3 years * asa physical status 1-2) who were scheduled for elective maxillofacial or genitourinary surgery. exclusion criteria:

Keywords: prevention of hypothermia pediatric patient cotton plastic wrap
vx-950 and peginterferon for hepatitis c

Conditions: Hepatitis C

Summary: vx-950 is an investigational drug , which is being tested in combination with a known treatment for hepatitis c, peginterferon.


Eligibility criteria:
inclusion criteria: * infected with hepatitis c virus exclusion criteria: * contraindications to peginterferon therapy
treatment of acute traumatic laceration of the olecranon and prepatellar bursa

Conditions: Traumatic Laceration of the Olecranon or Prepatellar Bursa

Summary: following a recent publication by the authors \[1\], there is no standardized treatment regime for the treatment of lacerations of the olecranon or prepatellar bursa, although primary bursectomy seems to be the most common treatment regime in germany, austria and switzerland. the aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the ob or pb treated, according to the local standards, either by bursectomy (vie, at) or bursal reconstruction and direct wound closure (muc, ger). \[1\] baumbach et al. evaluation of the current treatment concepts in germany, austria and switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. injury (2012)

a fall onto the elbow or knee often results in a laceration of the olecranon (ob) and prepatellar bursa (pb), due to their exposed and superficial location. although a common injury, the authors are not aware of any study dealing with this entity. in order to get a first idea on the treatment concepts currently used, the authors conducted a international online survey among orthopaedic and trauma surgeons in germany, austria and switzerland \[1\]. the primary treatment approach of more than 70% of austrian and german surgeons was bursectomy and immobilization, which was performed by less than 50% of swiss physicians. at the departments of trauma surgery of the medical university of vienna and of the medical university of munich, two opposing treatment concepts are being practised. whereas in vienna a bursectomy is performed in case of traumatic laceration of the ob and pb, a primary bursal reconstruction is performed at the medical university of munich. the aim of this study is to prospectively follow patients who suffered from an acute traumatic laceration of the ob or pb treated, according to the local standards, either by bursectomy (vie, at) or bursal reconstruction and direct wound closure (muc, ger). the hypothesis of this study is, that there is no difference with respect to complications between bursectomy and bursal reconstruction in case of acute traumatic laceration of the ob and pb. 1. baumbach et al. evaluation of the current treatment concepts in germany, austria and switzerland for acute traumatic lesions to the prepatellar and olecranon bursa. injury (2012)

Eligibility criteria:
inclusion criteria: * acute lacerations of the ob or pb (\<12h) * age 18 - 60 years * patient can read and understand german exclusion criteria: * immunodeficient patients * severe dementia * chronic alcoholism * conditions affecting the neuromuscular- or musculoskeletal system * previous surgical interventions at the same joint * conditions affecting wound healing (including chronic alcoholism, insulin dependent diabetes * neurological diseases * patient is not available for follow-up visits * patient suspected to be non-compliant * no major concomitant injuries

Keywords: olecranon prepatellar bursa trauma laceration bursectomy bursa reconstruction
increasing mat engagement with financial incentives

Conditions: Opioid-use Disorder

Summary: the increased prevalence of opioid use disorder (oud) and associated overdoses and adverse events has led to a substantial increase in the number of patients being seen at emergency departments (ed). thus, the ed may be an ideal location for identifying patients in need of oud treatment and can serve as the first touch point in the oud continuum of care to promote medication assisted treatment initiation. contingency management (cm) is an effective method for promoting treatment initiation and adherence that has not been thoroughly evaluated for this purpose. the primary aim of the current study is to develop and assess the effectiveness, acceptability, and feasibility of a protocol for delivering cm to increase combined buprenorphine + nalaxone (referred to as bup hereafter) initiation and continuous adherence for oud in an existing ed "bridge" program (e.g., bridge plus cm; b+cm) relative to standard care. secondary objectives include identifying behavioral and neuropsychological correlates to treatment outcomes, including delay discounting, reinforcer demand, and neurological soft signs.


Eligibility criteria:
inclusion criteria: 1. participants at least 18 years of age 2. participants must be newly enrolled in the bridge program in the cooper university ed, with their first clinic appointment scheduled to take place at the cooper outreach clinic within one week of enrollment. 3. all subjects must be in good physical health as determined by a physical examination and premenopausal women will have a pregnancy test on the day of the study to rule out pregnancy exclusion criteria: 1. participants who demonstrate contraindication with suboxone treatment or who are currently or have recently used other medication-assisted therapies for opioid use disorder. 2. participants who are currently pregnant or breastfeeding or have been diagnosed with a dsm-5 psychiatric condition that might interfere with treatment delivery (e.g., uncontrolled schizophrenia, bipolar disorder, dementia) 3. participants who are non-english speaking or cannot otherwise provide valid informed consent. 4. individuals who are unable to complete the survey assessments, due to literacy or visual impairments. 5. the participant will not be a prisoner
a randomised, double-blind, placebo controlled study with oralgen grass pollen rhinoconjunctivitis

Conditions: Allergic Rhinoconjunctivitis

Summary: this study will be performed to determine the long-term efficacy of 19.000 bu oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.

patients between 18 and 60 years will be randomized to receive either oralgen grass pollen or placebo administered sublingually once a day. treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. study medication will be titrated during the first period of treatment until maintenance dose has been reached.

Eligibility criteria:
inclusion criteria: * male or female * grass pollen related rhinoconjunctivitis symptoms for at least the last 2 pollen seasons * positive skin prick test rrtss greater or equal to 12 during the 2008 season * signed informed consent exclusion criteria: * positive skin prick test for other environmental allergens and suffering from serious allergic symptoms * clinical history of significant symptomatic allergic rhinitis due to tree/weed pollen which potentially overlap the grass pollen season * clinical history of symptomatic perennial allergic rhinitis caused by an allergen to which the patient is regularly exposed * lacking of good health * abnormal spirometry * lower respiratory tract infection * asthma requiring treatment other than beta-2 agonists * oral steroids within 12 weeks before screening * regular contraindications for use of immunotherapy

Keywords: randomised double-blind placebo-controlled efficacy and safety oralgen® grass pollen allergic rhinoconjunctivitis allergy rhinoconjunctivitis immunotherapy grass pollen extract